Cassette bag

ABSTRACT

A sterile container and method for enclosing a contaminated or non-sterile article therein wherein the sterile container comprises wall portions defining the sterile container which has a closed end and a cuff portion adjacent an open end and in overlying relation with the wall portions and a tubular insert having one end releasably held within the open end of the container by pressure-sensitive adhesive and the method for enclosing a non-sterile article in a sterile container comprises holding the sterile container by a sterile person while moving the article into the sterile container through the insert by a second person and effecting separation of the insert from the container by the second person while the sterile person holds the sterile container and then sealing the sterile container by exerting inwardly directed pressure on exterior surfaces of the container to effect contact between the pressure-sensitive adhesive on facing surfaces of the wall portions of the sterile container.

United States Patent [191 [4 Oct. 22, 1974 Oliverius 1 CASSETTE BAG [76] Inventor: Maynard F. Oliverius, 4020 Sena Dr., Topeka, Kans. 66600 [22] Filed: Aug. 28, 1972 [52] 11.1.8. C1 229/62, 128/292, 128/D1G. 24, 206/632 R [51] Int. Cl. 865d 33/20 [58] Field of Search 229/62; 206/632 R; 128/275, 292, 296, DIG. 24, 262; 150/3, 7

[56] References Cited UNITED STATES PATENTS 2,676,702 4/1954 Whitefoot, Jr. 206/632 R 2,766,927 10/1956 Wallace 229/62 2,819,010 1/1958 Amiguet 4 229/62' 3,073,507 1/1963 Trewella et a1. 229/62 3,301,466 1/1967 Perino et a1. 229/62 3,367,560 2/1968 Johnson 229/62 3,638,789 2/1972 Tuszewski 206/632 R Primary ExaminerWilliam 1. Price Assistant Examiner-Stephen P. Garbe Attorney, Agent, or Firm-Fishburn, Gold & Litman 5 7] ABSTRACT A sterile container and method for enclosing a contaminated or non-sterile article therein wherein the sterile container comprises wall portions defining the sterile container which has a closed end and a cuff portion adjacent an open end and in overlying relation with the wall portions and a tubular insert having one end releasably held within theopen end of the container by pressure-sensitive adhesive and the method for enclosing a non-sterile article in a sterile container comprises holding the sterile container by a sterile person while moving the article into the sterile container through the insert by a second person and effecting separation of the insert from the container by the second person while the sterile person holds the sterile container and then sealing the sterile container by exerting inwardly directed pressure on exterior surfaces of the container to effect contact between the pressure-sensitive adhesive on facing surfaces of the wall portions of the sterile container.

5 Claims, 7 Drawing Figures CASSETTE BAG The present invention relates to sterile containers and more particularly to a sterile container and a method for enclosing a non-sterile article therein, such as an X-ray cassette.

Currently one of the problems associated with surgery is sterilization of X-ray cassettes which are in the form of film holders usedwhen taking X-rays with either stationary or portable units. Sizes of X-ray cassettes vary from 8 X inches to about 12 X 18 inches and weigh up to 10 pounds. X-ray cassettes cannot be autoclaved due to heat and moisture problems and the effect thereof on the film. Exposing of the X-ray cassettes to ethylene oxide gas, which is another sterilizing agent, presents problems in addition to cost. Also ethylene oxide gas may create an adverse chemical reaction with the film thereby reducing its reproductive qualities. Use of ethylene oxide gas has been found to generate heat with the associated difficulties of heat with the X-ray film.

In surgery a non-sterile X-ray cassette must be isolated from the sterile site or field of the operation. l-Ieretofore, available containers were similar to plastic trash bags or sandwich bags. A third way to avoid contamination of the site or field was to place the dirty or contaminated X-ray cassette in a sterile pillow case, such as one which had been autoclaved. As a nonsterile person or nurse attempted to drop or move the contaminated or dirty cassette into the sterile bag, which was held open by a sterile nurse, the edges of the sterile bag were usually touched which would lead to contamination'of other surfaces. The problem created is for the sterile nurse holding the respective bag or pillow case receiving the contaminated article to get all of the contaminated edges placed or rolled to the inside and to be assured she is not also contaminated or that portions of the exterior of the bag are not contaminated.

The principal objects of the present invention are: to provide a sterile container adapted to receive a contaminated article therein which substantially eliminates the aforementioned difficulties; to provide such a sterile container which is operating room safe, namely formed of a material low in the generation of static electricity and free of particulate matter; to provide such a sterile container and method for enclosing a contaminated article therein which is adapted to maintain exterior surfaces of the container sterile whereby operating room personnel may position the container and the article enclosed therein next to an operative site with complete confidence that no contamination will be introduced into the field; to provide such a sterile container having a cuff portion thereon and positioned in overlying relation with wall portions of the sterile container and adjacent an open end thereof whereby a sterile person may position their hands in engagement with exterior surfaces of the sterile container and between the cuff portion and the sterile container; to provide such a sterile container wherein the cuff portion is maintained in a sterile condition before andafter receiving a contaminated article within the sterile container; to provide such a sterile container adapted to receive a contaminated article therein and which has means for effecting a positive closure of the container; and to provide such a sterile container adapted to receive a contaminated article therein, which is economical to manufacture, simple to use, positive in operation, and particularly well adapted for the proposed use.

Other objects and advantages of this invention will become apparent from the following description taken in connection with the accompanying drawings wherein are set forth by way of illustration and example certain embodiments of this invention.

The drawings constitute a part of the specification and include an exemplary embodiment of the present invention and illustrate various objects and features of the sterile container and method for enclosing a contaminated article therein.

FIG. I is a perspective view of a sterile container embodying features of the present invention and shown enclosed within an outer package.

FIG. 2 is a transverse sectional view through the sterile container and showing the relative positions of the component parts.

FIG. 3 is a transverse sectional view showing the sterile container held by a sterile person and a contaminated article being introduced into same by asecond person.

FIG. 4 is a transverse sectional view similar to FIGS. 2 and 3 except showing the contaminated article received within the sterile container.

FIG. 5 is a transverse sectional view showing an insert being removed from the sterile container.

FIG. 6 is a transverse sectional view showing the sterile container and insert after separation of the insert from the container.

FIG. 7 is a transverse sectional view showing the sealed sterile container.

Referring more in detail to the drawings:

As required, detailed embodiments of the present invention are disclosed herein. However, it is to be understood that the disclosed embodiments are merely exemplary of the invention which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriate detailed structure.

In the disclosed embodiment of the present invention, the reference numeral 1 generally designates a sterile container adapted to receive and enclose a contaminated article 2 therein. The sterile container 1 has wall portions defining the sterile container 1 which has a closed end 3 and a cuff portion 4 adjacent an open end 5 and in overlying relation with the wall portions and a tubular insert 6 having one end 7 thereof releasably held within the open end 5 of the container 1 by pressure-sensitive' adhesive 8 which is adapted to effect sealing of the open end 5 after separation of the insert 6 from the container 1 to thereby permit the contaminated article to be introduced into a sterile area. The method for enclosing the contamined article 2 in the sterile container 1 comprises holding the sterile container 1 by a sterile person 9 while moving the contaminated article 2 into the sterile container 1 through the insert 6 by a second person 10 and effecting separation of the insert 6 from the container l by the second person 10 while the sterile person 9 holds the sterile container l and then sealing the sterile container 1 by exerting inwardly directed pressure on exterior surfaces of the container 1 to effect contact between the pressure-sensitive adhesive '8 on facing surfaces of the wall portions of the container 1.

The sterile container 1 may be any desired shape to substantially conform to the shape of the contaminated article 2 to be received and enclosed therein. In the illustrated embodiment, the sterile container 1 is substantially rectangular to receive a generally rectangular article 2 and has opposed side walls 11 and 12 suitably jointed together along one edge thereof, as by heat scaling, to thereby define the closed end 3. Opposite end walls 13 and 14 extend between the side walls 11 and 12 and are preferably integral therewith to define an elongated generally tubular receptacle or container having the bottom closed to form the closed end 3.

The cuff portion 4 is preferably integral with the wall portions of the sterile container 1 and in the illustrated structure, the cuff portion 4 includes side walls 15 and 16 spaced from and in overlying relation with the side walls 11 and 12 respectively of the container 1 and includes opposite end wall portions 17 and 18 spaced from and in overlying relation with the end walls 13 and 14 respectively of the container 1.

The container 1 and the cuff portion 4 is to be sealed after the article 2 is positioned therein and the closed and sealed container will be placed in a sterile environment, such as an operating room. It is desirable that the material of the wall portions of the container 1 and the cuff portion 4 be suitable for use in operating rooms. Therefore, said wall portions are preferably formed of a non-woven fabric which is operating room safe, namely low in the generation of static electricity and substantially free of particulate matter, which could enter an incision. Plastics, such as polyethylene, polyvinyl chloride and the like have been found to provide satisfactory characteristics for the sterile container 1 and the cuff portion 4 when used in an operating room. Linen has also been found satisfactory for use in the sterile container 1.

The tubular insert 6 is illustrated as having wall portions defining a tubular member having the one end 7 thereof positioned within the open end of the container l and releasably held insaid position by the adhesive 8. It is desirable to provide maximum insulation or separation between the article 2 and the cuff portion 4 and the exterior surfaces of the wall portions of the container 1. Therefore, each of the wall portions of the insert 6 has inner and outer walls joined at a fold line 19 and the fold line 19 is positioned within the container l and adjacent the adhesive 8.

In the illustrated embodiment, the tubular insert 6 has outer side walls 20 and 21 spaced from and in over lying relation with the side walls and 16 respectively of the cuff portion 4 and inner side walls 22 and 23 in overlying relation with the outer side walls and 21 respective of the tubular insert 6. The tubular insert 6 has outer end walls 24 and 25 in overlying relation with the end walls 17 and 18 respectively of the cuff portion 4 and inner end walls 26 and 27 in overlying relation with the outer end walls 24 and 25 respectively of the tubular insert 6.

The adhesive 8 is mounted on interior surfaces of the wall portions of the sterile container and in a continuous band spaced inwardly from the open end 5. The adhesive 8 is mounted on interior surfaces of the side walls 11 and 12 and the end walls 13 and 14 the adhesive 8 is preferably of the pressure-sensitive type which will releasably hold the one end 7 of the tubular insert the sterile container 1.

The sterile container 1 is preferably packaged and sealed within an outer package 28 which is also preferably formed of a material which is safe for use in operating rooms, such as non-woven plastic fabrics including polyethylene, polyvinyl chloride, and the like. The outer package 28 preferably has wall portions formed of a material which will substantially resist movement into the package of any agent which will contaminate an article therein, therefore, the wall portions of the outer package 28 are formed of a suitable nonwoven fabric, such as paper polyethylene, polyvinyl chloride, and the like.

It is desirable that the outer container 28 be sealed in a manner which will maintain the interior surfaces thereof and an article therein in a sterile condition and which may be opened in a'manner to maintain the interior surfaces of the outer package 28 and the sterile container 1 in a sterile condition particularly during removal of the sterile container 1 from the outer package 28. Heat sealing of plastic to plastic and plastic to paper have been found to provide such a seal which can be opened by a non-sterile person while maintaining the sterile container 1 in a sterile condition.

Using a sterile container for enclosing a contaminated article therein and constructed as illustrated and described is effective to enclose the article 2 within the container 1 without contaminating exterior surfaces of the sterile container 1 and the cuff portion 4 or a sterile person holding same. The sterile outer package 28 is opened by any suitable person, such as a circulating nurse, and the sterile container 1 is dumped onto a sterile field, such as a sterile table covered with a sterile sheet or the like. The sterile container 1- is removed from the sterile field or removed from the sterile outer package 28 by the sterile person 9 who then holds the container 1 by placing their hands on or adjacent exterior surfaces of the wall portions, more particularly, the side walls 11 and 12 of the container 1 and under the cuff portion 4 with at least the tips of the fingers in supporting engagement with the cuff portion 4. The container 1, so supported, is adapted to receive the article 2 which is moved thereinto by the second person 10 by moving the article 2 through the insert 6. The article 2 may' come into engagement with exposed surfaces of the inner side walls 22 and 23 and the inner end walls 26 and 27 of the tubular insert 6. After the article 2 is moved into the container 1, the tubular insert 6 is then separated from the container 1 by pulling on the inner side walls 22 and 23 of the insert 6 by the second person 10 while the sterile person 9 holds the sterile container 1. FIGS. 5 and 6 illustrate the separation of the insert 6 from the container 1 and the possible areas of contamination are facing surfaces of the inner side walls 22 and 23 and the inner end walls 26 and 27 and exterior surfaces of said walls where gripped by the second person 10 during separation of the insert 6 from the container 1. After the insert 6 has been separated from the container 1, the sterile container 1 having the contaminated article therein is sealed by the sterile person 9 by exerting inwardly directed pressure on exterior surfaces of the wall portions of the container 1,

more particularly, on the side walls ill and 12 to thereby effect contact between the pressure sensitive adhesive 8 on facing interior surfaces of said side walls 11 and 12. The end walls 13 and M are folded to permit a continuous seal of the container 1 by closing the formerly open end 5.

The sterile container l is particularly adapted for receiving X-ray cassettes of a size in the range of 8 X inches to approximately 12 X 18 inches, whereby the X ray cassette or contaminated article 2 may be taken from a non-sterile area by the second person it) and placed in the sterile container ll while the container l is held by the sterile person 9, who after sealing the formerly open end 5, may place the container and cassette adjacentor in contact with an area to be X-rayed without fear of contamination of the patient and without the necessity to sterilize the X-ray cassettes.

It is to be understood that while I have illustrated and described one form of my invention, it is not to be limited to the specific form or arrangement of parts herein described and shown.

What I claim and desire to secure by Letters Patent is:

l. A sterile container adapted to receive a nonsterile article therein and comprising:

a. wall portions defining a container having a closed end and an open end:

b. a cuff portion on said container and in overlying relation with the wall portions adjacent the open end of said container;

c. an insert having wall portions defining a tubular member having one end thereof positioned within the open end of said container, said insert wall portions extending from within the container with outer portions overlying the cuff portion adjacent the open end of the container whereby the insert wall portions protect the container open, end and cuff from contact with a non-sterile article moved through the insert and into the container; and

(1. means on said container for releasably holding the one end of said insert in the open end of said container, said means being operative to seal the container whereby a non-sterile article moved through said insert and into said container may be sealed therein after separation of said insert from said container to thereby provide a sterile package of a non-sterile article which may be safely introduced into a sterile area.

2. A sterile container as set forth in claim ll wherein the non-sterile article which the container is adapted to receive is an X-ray cassette and said container and cuff portion and insert are formed of a non-woven plastic fabric characterized by being substantially free of static electricity whereby the sterile container is adapted to be placed in an operating room.

3. A sterile container adapted to receive a non-sterile article therein and comprising:

a. wall portions defining a container having a closed end and an open end, said wall portions being formed of a non-woven fabric;

b. a cuff portion integral with said wall portions of said container and in overlying relation with said wall portions of said container and extending from the open end of said container, said cuff portion being formed of a non-woven fabric;

c. an insert having wall portions defining a tubular member having one end portion extending into said container through the open end thereof, said insert having the other end portion thereof in overlying relation with said cuff portion to protect same from contact with an article moved through the insert into the container; and

d. adhesive means on said container walls in a band inside of said container adjacent the open end thereof and underlying said one end portion of said insert for releasably holding the one end portion of said insert in the open end of said container, said adhesive means being pressure-sensitive whereby said wall portions of said container may be sealed together after separation removal removalk of said insert from said container.

4. A sterile container adapted to receive a non-sterile article therein and comprising:

a. wall portions defining a container having a closed end and an open end;

b. a cuff portion on said container and in overlying relation with the wall portions adjacent the open end of said container;

c. said cuff portion being integral with said wall portions of said container and extending from the open end thereof;

d. an insert having wall portions defining a tubular member having one end thereof positioned within the open end of said container;

e. each of said wall portions of said insert having an inner wall and an outer wall joined ata fold line; f. means on said container for releasably holding the one end of said insert in the open end of said container, said means being operative to seal the container whereby a non-sterile article moved through said insert and into said container may be sealed therein after separation of said insert from said container to thereby permit a non-sterile article to be introduced into a sterile area;

g. said fold line of said insert being positioned within said container and adjacent said means.

5. A sterile container adapted to receive a non-sterile article therein and comprising:

a. wall portions defining a container having a closed end and an open end, said wall portions being formed of a non-woven fabric;

b. a cuff portion integral with said wall portions of said container and in overlying relation with said wall portions of said container and extending from the open end of said container, said cuff portion being formed of a non-woven fabric;

0. an insert having wall portions defining a tubular member having one end thereof positioned within the open end of said container, said insert having the other end thereof in overlying relation with said cuff portion;

d. each of said wall portions of said insert having an inner wall and an outer wall joined at a fold line; e. adhesive means on said container for releasably holding the one end of said insert in the open end of said container, said adhesive means being pressure-sensitive whereby said wall portions of said container may be sealed together after separation of said insert from said container;

said fold line being positioned within said container and adjacent said adhesive means;

g. said inner wall and said outer wall of said wall portions of said insert each having the other end thereof in overlying relation with said cuff portion. =t= l= =l V 

1. A sterile container adapted to receive a non-sterile article therein and comprising: a. wall portions defining a container having a closed end and an open end: b. a cuff portion on said container and in overlying relation with the wall portions adjacent the open end of said container; c. an insert having wall portions defining a tubular member having one end thereof positioned within the open end of said container, said insert wall portions extending from within the container with outer portions overlying the cuff portion adjacent the open end of the container whereby the insert wall portions protect the container open end and cuff from contact with a non-sterile article moved through the insert and into the container; and d. means on said container for releasably holding the one end of said insert in the open end of said container, said means being operative to seal the container whereby a non-sterile article moved through said insert and into said container may be sealed therein after separation of said insert from said container to thereby provide a sterile package of a non-sterile article which may be safely introduced into a sterile area.
 2. A sterile container as set forth in claim 1 wherein the non-sterile article which the container is adapted to receive is an X-ray cassette and said container and cuff portion and insert are formed of a non-woven plastic fabric characterized by being substantially free of static electricity whereby the sterile container is adapted to be placed in an operating room.
 3. A sterile container adapted to receive a non-sterile article therein and comprising: a. wall portions defining a container having a closed end and an open end, said wall portions being formed of a non-woven fabric; b. a cuff portion integral with said wall portions of said container and in overlying relation with said wall portions of said container and extending from the open end of said container, said cuff portion being formed of a non-woven fabric; c. an insert having wall portions defining a tubular member having one end portion extending into said container through the open end thereof, said insert having the other end portion thereof in overlying relation with said cuff portion to protect same from contact with an article moved through the insert into the container; and d. adhesive means on said container walls in a band inside of said container adjacent the open end thereof and underlying said one end portion of said insert for releasably holding the one end portion of said insert in the open end of said container, said adhesive means being pressure-sensitive whereby said wall portions of said container may be sealed together after separation removal removalk of said insert from said container.
 4. A sterile container adapted to receive a non-sterile article therein and comprising: a. wall portions defining a container having a closed end and an open end; b. a cuff portion on said container and in overlying relation with the wall portions adjacent the open end of said container; c. said cuff portion being integral with said wall portions of said container and extending from the open end thereof; d. an insert having wall portions defining a tubular member having one end thereof positioned within the open end of said container; e. each of said wall portions of said insert having an inner wall and an outer wall joined at a fold line; f. means on said container for releasably holding the one end of said insert in the open end of said container, said means being operative to seal the container whereby a non-sterile article moved through said insert and into said container may be sealed therein after separation of said insert from said container to thereby permit a non-sterile article to be introduced into a sterile area; g. said fold line of said insert being positioned within said container and adjacent said means.
 5. A sterile container adapted to receive a non-sterile article therein and comprising: a. wall portions defining a container having a closed end and an open end, said wall portions being formed of a non-woven fabric; b. a cuff portion integral with said wall portions of said container and in overlying relation with said wall portions of said container and extending from the open end of said container, said cuff portion being formed of a non-woven fabric; c. an insert having wall portions defining a tubular member having one end thereof positioned within the open end of said container, said insert having the other end thereof in overlying relation with said cuff portion; d. each of said wall portions of said insert having an inner wall and an outer wall joined at a fold line; e. adhesive means on said container for releasably holding the one end of said insert in the open end of said container, said adhesive means being pressure-sensitive whereby said wall portions of said container may be sealed together after separation of said insert from said container; said fold line being positioned within said container and adjacent said adhesive means; g. said inner wall and said outer wall of said wall portions of said insert each having the other end thereof in overlying relation with said cuff portion. 